Skip to main content

Recalls & Field Safety Actions

Medical device recalls in India may be voluntary (initiated by the manufacturer) or CDSCO-directed. All recalls require a Field Safety Notice (FSN) to customers and coordination with CDSCO via the SUGAM vigilance module.

Official source: Medical Devices Rules 2017, Schedule 7; CDSCO

Recall Classification in India

Medical device recalls are classified based on severity and risk to public health:

  • Class I: Device poses serious adverse health consequences or death
  • Class II: Device may cause adverse health consequences but severity is not as serious as Class I
  • Class III: Device is unlikely to cause adverse health consequences

Classification determines the urgency of communication, scope of recall, and CDSCO reporting requirements. Recalls may be expanded or downgraded based on evolving safety information.